Trial Outcomes & Findings for An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent (NCT NCT01641952)

NCT ID: NCT01641952

Last Updated: 2016-08-17

Results Overview

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\], and ESR. DAS28 total scores range from 0 to 10. DAS28 \<=3.2 indicates low disease activity, DAS28 \>3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 \<=3.2 and a CFB \>1.2. Moderate response: DAS28 \<=3.2 and CFB \>0.6 to \<=1.2, DAS28 \>3.2 to \<=5.1 and CFB \>1.2 or \>0.6 to \<=1.2, DAS28 \>5.1 and CFB \>1.2. No response: DAS28 \<=3.2 and CFB \>=0.6, DAS28 \>3.2 to \<=5.1 and CFB \<=0.6, DAS28 \>5.1 and CFB \>0.6 to \<=1.2 or \<=0.6.

• Recruitment status: COMPLETED
• Target enrollment: 505 participants
• Primary outcome timeframe: Week 20
• Results posted on: 2016-08-17

Participant Flow

A total of 505 participants were recruited in 58 centers.

Participant milestones

Measure	Rituximab Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Overall Study STARTED	505
Overall Study Treated	504
Overall Study COMPLETED	471
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Measure	Rituximab Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Overall Study Lost to Follow-up	28
Overall Study Adverse Event	6

Baseline Characteristics

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

Baseline characteristics by cohort

Measure	Rituximab n=505 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Age, Continuous	56.36 years STANDARD_DEVIATION 10.681 • n=5 Participants
Sex: Female, Male Female	434 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria Present <=3.2; CFB >1.2	0 percentage of participants
Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria Present >5.1; CFB >1.2	14.54 percentage of participants
Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria Present <=3.2; CFB >0.6 to <=1.2	8.20 percentage of participants
Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria Present >3.2 to <=5.1; CFB >1.2	43.03 percentage of participants
Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria Present >3.2 to <=5.1; CFB >0.6 to <=1.2	9.00 percentage of participants

PRIMARY outcome

Timeframe: Baseline and Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity]. DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.

Outcome measures

Measure	Rituximab n=489 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Change From Baseline in DAS28-ESR at Week 20	-1.53458 units on a scale Interval -1.66 to -1.4

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Mean DAS28-ESR Score at Visit 4 (Week 20)	3.8218 units on a scale Standard Deviation 1.26061

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment	57.99 percentage of participants

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Percentage of Participants With EULAR Response Present <=3.2; CFB <=0.6	17.62 percentage of participants
Percentage of Participants With EULAR Response Present >5.1; CFB >1.2	14.54 percentage of participants
Percentage of Participants With EULAR Response Present <=3.2; CFB>1.2	0 percentage of participants
Percentage of Participants With EULAR Response Present <=3.2; CFB>0.6 to <=1.2	8.20 percentage of participants
Percentage of Participants With EULAR Response Present >3.2 to <=5.1; CFB >1.2	43.03 percentage of participants
Percentage of Participants With EULAR Response Present >3.2 to <=5.1; CFB >0.6 and <=1.2	9.00 percentage of participants
Percentage of Participants With EULAR Response Present >3.2 to <=5.1; CFB <=0.6	0 percentage of participants
Percentage of Participants With EULAR Response Present >5.1; CFB >0.6 to <=1.2	0 percentage of participants
Percentage of Participants With EULAR Response Present >5.1; CFB <=0.6	0 percentage of participants
Percentage of Participants With EULAR Response No improvement	8 percentage of participants

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously No treatment; DAS 28 >3.2 to <=5.1	0 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously No treatment; DAS 28 >5.1	0.83 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Actemra; DAS 28 >3.2 to <=5.1	0 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Actemra; DAS 28 >5.1	4.16 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Certolizumab; DAS 28 >3.2 to <=5.1	0 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Certolizumab; DAS 28 >5.1	0.83 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Golimumab; DAS 28 >3.2 to <=5.1	0 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Golimumab; DAS 28 >5.1	10 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Rituximab; DAS 28 >3.2 to <=5.1	0 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Rituximab; DAS 28 >5.1	3.33 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Tocilizumab; DAS 28 >3.2 to <=5.1	40.83 percentage of participants
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously Tocilizumab; DAS 28 >5.1	40 percentage of participants

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course Low Disease Activity	15 percentage of participants
Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course Remission (DAS28 <2.6)	16.19 percentage of participants

PRIMARY outcome

Timeframe: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab Adalimumab	18 participants
Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab Etanercept	18 participants
Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab Infliximab	24 participants

PRIMARY outcome

Timeframe: Up to 39 months

Population: Safety population included all participants who received at least one dose of study treatment.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	Rituximab n=504 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Number of Participants With Adverse Events (AE)	16 participants

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Intent to treat population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated to the screening exam, and have completed the baseline visit and at least one further assessment. Here, number of participant analysed is the participants who were evaluable for this outcome measure.

HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.

Outcome measures

Measure	Rituximab n=488 Participants Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Health Assessment Questionnaire (HAQ) Score at Week 20 Baseline	2.62 units on a scale Standard Deviation 0.737
Health Assessment Questionnaire (HAQ) Score at Week 20 Week 20	1.85 units on a scale Standard Deviation 0.715

Adverse Events

Rituximab

Serious events: 14 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rituximab n=504 participants at risk Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Injury, poisoning and procedural complications Hypothermia	0.20% 1/504 • up to 39 months
Vascular disorders Accelerated hypertension	0.20% 1/504 • up to 39 months
Metabolism and nutrition disorders Blood triglycerides increased	0.20% 1/504 • up to 39 months
Vascular disorders Peripheral venous disease	0.40% 2/504 • up to 39 months
Nervous system disorders Parkinson Diseases	0.20% 1/504 • up to 39 months
Surgical and medical procedures Leg amputation	0.20% 1/504 • up to 39 months
Injury, poisoning and procedural complications Allergic transfusion reaction	0.20% 1/504 • up to 39 months
Infections and infestations Brain abscess	0.20% 1/504 • up to 39 months
Gastrointestinal disorders Oral cavity cancer metastatic	0.20% 1/504 • up to 39 months
Hepatobiliary disorders Cholelithiasis	0.20% 1/504 • up to 39 months
Blood and lymphatic system disorders Leukopenia	0.20% 1/504 • up to 39 months
Blood and lymphatic system disorders Anaemia	0.20% 1/504 • up to 39 months
Immune system disorders Systemic inflammatory response syndrome	0.20% 1/504 • up to 39 months
Infections and infestations Influenza	0.20% 1/504 • up to 39 months
Injury, poisoning and procedural complications Instillation site urticaria	0.40% 2/504 • up to 39 months
Immune system disorders Anaphylactic shock	0.20% 1/504 • up to 39 months
Nervous system disorders Seizure	0.20% 1/504 • up to 39 months
Respiratory, thoracic and mediastinal disorders Pulmonary tuberculosis	0.20% 1/504 • up to 39 months

Other adverse events

Measure	Rituximab n=504 participants at risk Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Investigations Blood iron decreased	0.20% 1/504 • up to 39 months
Immune system disorders Chronic gastritis	0.20% 1/504 • up to 39 months
Infections and infestations Tooth abscess	0.20% 1/504 • up to 39 months
Skin and subcutaneous tissue disorders Dermatitis bullous	0.20% 1/504 • up to 39 months

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER